SUPPLY CHAIN ARTICLES

  • What Violin Making Can Teach Us About mRNA Therapeutic Quality

    Managing the mRNA supply chain and working in mRNA process development may not look anything like the work a luthier does to hew an instrument from an ancient spruce tree. But violin craftmanship actually serves as a fantastic metaphor for the challenging work the mRNA therapeutics space is tackling in sourcing and qualifying raw materials and optimizing the critical IVT reaction.

  • How Can We Move RNA Forward In Our Therapeutics Arsenal?

    RNA technologies, including mRNA therapeutics, have emerged as a promising drug modality. However, they have unique challenges. BioPhorum has dedicated a team to investigate these challenges and this Q&A shares their practical considerations for how to move this field forward.

  • 4 Risk Mitigation Strategies For mRNA Production

    Planning and procuring custom materials needed to manufacture mRNA remains a top concern. This article shares risk mitigation strategies for multi-sourcing, S&OP process, packaging size, and material expiry.

  • The RNA Therapeutics Supply Chain: A Platform of Relationships

    Conversations digging into RNA-specific sourcing considerations have been few and far between. Enter Sanofi's Greg Troiano. Together, we delved into the nuances, challenges, and opportunities for growth that currently exist within the mRNA drug substance and drug product (i.e., mRNA-LNP) raw material sourcing worlds.

  • Moderna & The Global mRNA Supply Chain: Regulatory Lessons Learned

    One of the most important reminders I took away from Moderna’s experiences ushering its mRNA vaccine onto the global market is that a commercial manufacturing process must also be accompanied by a commercially ready supply chain. Though sufficient physical volumes of each raw material and a redundant supplier network are necessities, physical scale is not the only “CQA” for which we must account when commercializing our supply chain. 

  • mRNA Vaccines: Key Considerations For Development & Manufacturing

    As we wind down National Immunization Awareness Month, this article looks at the complexities around developing and manufacturing mRNA vaccines and how you should address those complexities. Topics include delivery, process validation, long-term effectiveness, GMP, regulatory approval, and more. 

SUPPLY CHAIN VIDEOS

As our molecules grow more complicated, so, too, does the supply chain. Here, Advancing RNA Live speakers Khaled Yamout & Camp4’s Satya Kuchimanchi talk through how this growth challenges our understanding of raw material quality and how sponsors can better assess their suppliers.

Explore a state-of-the-art GMP facility focused on CRISPR based Cell and Gene therapies with helping temperature controlled warehouse and multiple synthesis suites.

Hosted by Cell & Gene Collaborative's Director Anna Rose Welch, ARW on RNA puts a creative spin on the emerging mRNA + RNA therapeutics industry. Here, in Episode 3, Welch explores the similarities that exist between the art of crafting a high quality violin and the upstream process development work mRNA therapeutics experts are performing today to create the most ideal mRNA drug substance.

With benefits across applications, nanoplasmids are designed to replace antiquated bacterial backbones, while eliminating antibiotic markers that can cause regulatory concerns.

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS